1188HD CCU 1188010000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-11-17 for 1188HD CCU 1188010000 manufactured by Stryker Endoscopy San Jose.

Event Text Entries

[2502436] It was reported that the unit went blank during use.
Patient Sequence No: 1, Text Type: D, B5

[9572805] Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2936485-2011-00908
• MDR Report Key: 2382375
• Report Source: 00
• Date Received: 2011-11-17
• Date of Report: 2011-11-01
• Date of Event: 2011-11-01
• Date Mfgr Received: 2011-11-01
• Date Added to Maude: 2012-07-16
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: SUNNY OFFORJEBE
• Manufacturer Street: 5900 OPTICAL CT.
• Manufacturer City: SAN JOSE CA 95138
• Manufacturer Country: US
• Manufacturer Postal: 95138
• Manufacturer Phone: 1087542000
• Manufacturer G1: STRYKER ENDOSCOPY SAN JOSE
• Manufacturer Street: 5900 OPTICAL CT.
• Manufacturer City: SAN JOSE CA 95138
• Manufacturer Country: US
• Manufacturer Postal Code: 95138
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 1188HD CCU
• Generic Name: CAMERA CONTROL UNIT
• Product Code: FXM
• Date Received: 2011-11-17
• Returned To Mfg: 2011-11-14
• Catalog Number: 1188010000
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER ENDOSCOPY SAN JOSE
• Manufacturer Address: SAN JOSE CA 95138 US 95138

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-11-17